System and method for computationally determining migration of neurostimulation leads

ABSTRACT

A tissue stimulation system and computer software and method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient (e.g., adjacent the spinal cord) is provided. Neurostimulation lead models are provided, each of which includes estimated electrical parameter data (e.g., electrical field potential data) corresponding to a predetermined position of the neurostimulation lead. Electrical energy is transmitted to or from the electrodes, and electrical parameter data (e.g., electrical field potential data) is measured in response to the transmitted electrical energy. The measured electrical parameter data is compared with the estimated electrical parameter data of each of the neurostimulation lead models, and a position of the neurostimulation lead is determined based on the comparison.

FIELD OF THE INVENTION

The present invention relates to tissue stimulation systems, and moreparticularly, to systems and methods for determining the migration ofneurostimulation leads.

BACKGROUND OF THE INVENTION

Spinal cord stimulation (SCS) is a well-accepted clinical method forreducing pain in certain populations of patients. During SCS, the spinalcord, spinal nerve roots, or other nerve bundles are electricallystimulated using one or more neurostimulation leads implanted adjacentthe spinal cord. While the pain-reducing effect of SCS is not wellunderstood, it has been observed that the application of electricalenergy to particular regions of the spinal cord induces paresthesia(i.e., a subjective sensation of numbness or tingling) that replaces thepain signals sensed by the patient in the afflicted body regionsassociated with the stimulated spinal regions. Thus, the paresthesiaappears to mask the transmission of chronic pain sensations from theafflicted body regions to the brain.

The working clinical paradigm is that achievement of an effective resultfrom SCS depends on the neurostimulation lead or leads being placed in alocation (both longitudinal and lateral) relative to the spinal tissuesuch that the electrical stimulation will induce paresthesia located inapproximately the same place in the patient's body as the pain (i.e.,the target of treatment). If a lead is not correctly positioned, it ispossible that the patient will receive little or no benefit from animplanted SCS system. Thus, correct lead placement can mean thedifference between effective and ineffective pain therapy.

In a typical procedure, one or more stimulation leads are introducedthrough the patient's back into the epidural space under fluoroscopy.Stimulation energy may be delivered to the electrodes of the leadsduring and after the placement process in order to verify that the leadsare stimulating the target neural tissue. Stimulation energy is alsodelivered to the electrodes at this time to formulate the most effectiveset of stimulus parameters, which include the electrodes that aresourcing (anodes) or returning (cathodes) the stimulation pulses at anygiven time, as well as the magnitude and duration of the stimulationpulses. During the foregoing procedure, an external trialneurostimulator may be used to convey the stimulation pulses to thelead(s), while the patient provides verbal feedback regarding thepresence of paresthesia over the pain area. The stimulus parameter setwill typically be one that provides stimulation energy to all of thetarget tissue that must be stimulated in order to provide thetherapeutic benefit (e.g., pain relief), yet minimizes the volume ofnon-target tissue that is stimulated. Thus, neurostimulation leads aretypically implanted with the understanding that the stimulus parameterset will require fewer than all of the electrodes on the leads toachieve the desired paresthesia.

After the lead(s) are placed at the target area of the spinal cord, thelead(s) are anchored in place, and the proximal ends of the lead(s), oralternatively lead extensions, are passed through a tunnel leading to asubcutaneous pocket (typically made in the patient's abdominal area)where a neurostimulator is implanted. The lead(s) are connected to theneurostimulator, which is programmed with the stimulation parameterset(s) previously determined during the initial placement of thelead(s). The neurostimulator may be operated to test the effect ofstimulation and, if necessary, adjust the programmed set(s) ofstimulation parameters for optimal pain relief based on verbal feedbackfrom the patient. Based on this feedback, the lead position(s) may alsobe adjusted and re-anchored if necessary. Any incisions are then closedto fully implant the system.

A wide variety of neurostimulation leads have been introduced. Onecommon type of neurostimulation lead is the percutaneous lead, whichincludes a plurality of spaced electrodes on a small diameter lead body.Percutaneous leads are relatively easy to place because they can beinserted into the epidural space adjacent the spinal cord through apercutaneous needle in a small locally-anesthetized incision while thepatient is awake and able to provide feedback. One of the disadvantagesof percutaneous leads, however, is that they are prone to migrating inthe epidural space, either over time or as a result of sudden flexionmovement.

Lead migration may relocate the paresthesia away from the pain site,resulting in the target neural tissue no longer being appropriatelystimulated and the patient no longer realizing the full intendedtherapeutic benefit. With electrode programmability, the stimulationarea can often be moved back to the effective pain site without havingto reoperate on the patient in order to reposition the lead. Leadmigration is, however, not the only reason that the therapeutic effectsof a previously effective neurostimulation regimen will diminish orsimply disappear, which can make diagnosis difficult. Moreover, evenafter a physician has determined that lead migration has occurred andthat the system must be reprogrammed to accommodate the new positions ofthe electrodes, conventional neurostimulation systems do not provide thephysician with information about the movement of an individual lead,such as how far one lead has moved relative to another lead. Knowledgeof relative lead displacement is important, because the resultingmisalignment of the anodes and cathodes of the respective leads changesthe stimulation pattern, thereby degrading the therapy provided by theSCS. Without such knowledge, the previous stimulation pattern willlikely have to be recovered through trial and error and patientfeedback, making reprogramming of the electrodes especially difficult.

It is possible to image the patient's spinal column using conventionalimaging modalities, such as fluoroscopy, to determine the occurrence andextent of lead migration. However, use of conventional imaging systems,which are often not readily available, is inconvenient and costly. Inaddition, detection of lead migration via conventional imaging cannot beperformed remotely. Furthermore, it may be desirable to automaticallyprogram electrodes in response to detection of lead migration. However,the use of conventional imaging modalities to detect lead migration isnot suitable for automated electrode programmability.

There, thus, remains a need for an improved method and system fordetermining the occurrence and extent of neurostimulation lead migrationin a patient.

SUMMARY OF THE INVENTION

In accordance with the present inventions, a method of monitoring aneurostimulation lead having a plurality of electrodes implanted withina patient (e.g., adjacent the spinal cord) is provided. The methodcomprises providing a plurality of neurostimulation lead models, each ofwhich includes estimated electrical parameter data (e.g., electricalfield potential data) corresponding to a predetermined position of theneurostimulation lead. Each of the neurostimulation lead models, may be,e.g., an analytical model, spatially discretized model, or an empiricaldata-based model.

The method further comprises transmitting electrical energy to or fromthe electrodes, and measuring electrical parameter data (e.g.,electrical field potential data) in response to the transmittedelectrical energy. Electrical energy may be transmitted between theelectrodes and another electrode or other electrodes (e.g., electrodeson another neurostimulation lead, a case of an implantable pulsegenerator, or other electrodes implanted within the patient). The methodfurther comprises comparing the measured electrical parameter data withthe estimated electrical parameter data of each of the neurostimulationlead models. In one method, the comparison is performed computationally;for example, using a comparison function, such as a correlationcoefficient function, a least squares based function, or across-correlation function.

The method further comprises determining a position of theneurostimulation lead based on the comparison. In one method, thedetermined position is the predetermined position corresponding to theestimated electrical parameter data that best matches the measuredelectrical parameter data. In another method, the position of theneurostimulation lead is determined relative to another neurostimulationlead implanted within the patient. For example, if the neurostimulationleads are implanted in a side-by-side arrangement, the determinedrelative position may be a stagger between the neurostimulation leads.In other methods, the position of the neurostimulation lead may bedetermined relative to an anatomical feature. An optional method furthercomprises determining whether the neurostimulation lead has migratedbased on the determined position, and taking corrective action (e.g.,reprogramming the electrodes) in response to a determination that aneurostimulation lead has migrated.

The afore-described methods can be implemented in a computer readablemedium. For example, the medium may contain instructions, which whenexecuted, accesses the neurostimulation lead models, compares themeasured electrical parameter data with the estimated electricalparameter data of each of the neurostimulation lead models, anddetermines the position of the neurostimulation lead based on thecomparison.

The afore-described methods can also be implemented in a tissuestimulation system. The system may include the implantableneurostimulation lead, the plurality of neurostimulation lead models, acontroller configured for transmitting electrical energy to or from theelectrodes and measuring the electrical parameter data in response tothe transmitted electrical energy, and a processor configured forcomparing the measured electrical parameter data with the estimatedelectrical parameter data of each of the neurostimulation lead models,and determining the position of the neurostimulation lead based on thecomparison.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is plan view of one embodiment of a spinal cord stimulation (SCS)system arranged in accordance with the present inventions;

FIG. 2 is a profile view of an implantable pulse generator (IPG) used inthe SCS system of FIG. 1;

FIG. 3 is a schematic view illustrating current-controlled circuitry ofthe IPG of FIG. 2;

FIG. 4 is an exemplary stimulation pulse generated by thecurrent-controlled circuitry of FIG. 3;

FIG. 5 is a schematic view illustrating alternative voltage-controlledcircuitry that can be used in the IPG of FIG. 2;

FIG. 6 is an exemplary stimulation pulse generated by thecurrent-controlled circuitry of FIG. 5;

FIG. 7 is a plan view showing the implantation of neurostimulation leadsused in the SCS system of FIG. 1, wherein the leads are particularlyshown in their baseline positions;

FIG. 8 is a plan view showing the implantation of neurostimulation leadsused in the SCS system of FIG. 1, wherein one of the leads isparticularly shown in their migrated positions;

FIG. 9 is a perspective view of a comparison between actual datameasured by the SCS system of FIG. 1 and a plurality of neurostimulationlead models having estimated data stored in the SCS system of FIG. 1;

FIG. 10 is a one embodiment of a table containing a two-dimensionalarray of data measured in the SCS system of FIG. 1;

FIG. 11 is an alternative embodiment of a table containing atwo-dimensional array of data measured in the SCS system of FIG. 1;

FIG. 12 is a plot of a Pearson Correlation Coefficient function used tocompare measured voltage potential data with estimated voltage potentialdata contained in neurostimulation lead models; and

FIG. 13 is a plot of a sum of squared differences function used tocompare measured voltage potential data with estimated voltage potentialdata contained in neurostimulation lead models.

DETAILED DESCRIPTION OF THE EMBODIMENTS

At the outset, it is noted that the present invention may be used withan implantable pulse generator (IPG), radio frequency (RF) transmitter,or similar electrical stimulator, that may be used as a component ofnumerous different types of stimulation systems. The description thatfollows relates to a spinal cord stimulation (SCS) system. However, itis to be understood that the while the invention lends itself well toapplications in SCS, the invention, in its broadest aspects, may not beso limited. Rather, the invention may be used with any type ofimplantable electrical circuitry used to stimulate tissue. For example,the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical and deepbrain stimulator, or in any other neural stimulator configured to treaturinary incontinence, sleep apnea, shoulder sublaxation, etc.

Turning first to FIGS. 1 and 2, an exemplary SCS system 10 generallyincludes first and second implantable neurostimulation leads 12, 14, animplantable pulse generator (IPG) 16, and an external (non-implanted)programmer 18. In the illustrated embodiment, the leads 12, 14 arepercutaneous leads and, to that end, both of the leads comprise aplurality of in-line electrodes 20 carried on a flexible body 22. In theillustrated embodiment, the first lead 12 has eight electrodes 20, whichare labeled E1-E8, and the second lead 14 includes eight electrodes 20,which are labeled E9-E16. The actual number of leads and electrodeswill, of course, vary according to the intended application. The leads12, 14 are intended to be implanted adjacent to the patient's spinalcolumn through the use of a percutaneous needle or other conventiontechnique. Once in place, the electrodes 20 may be used to supplystimulation energy to the spinal cord or nerve roots.

The IPG 16 is capable of directing electrical stimulation energy to eachof the electrodes 20. To that end, the electrodes 20 of the first lead12 are electrically connected to the IPG 16 by respective signal wires24 (some of which are not shown) that extend through, or are embeddedin, the associated flexible lead body 22. Similarly, the electrodes 20of the second lead 14 are electrically connected to the IPG 16 byrespective wires 26 (some of which are not shown). The signal wires 24,26 are connected to the IPG 16 by way of an interface 28. The interface28 may be any suitable device that allows the leads 12, 14 to beremovably or permanently electrically connected to the IPG 16. Such aninterface may, for example, be an electro-mechanical connectorarrangement including lead connectors 30 a, 30 b within the IPG 16 thatare configured to mate with corresponding connectors (only connector 32a is shown) on the corresponding leads 12, 14. Alternatively, the leads12, 14 can share a single connector that mates with a correspondingconnector on the IPG 16. Exemplary connector arrangements are disclosedin U.S. Pat. Nos. 6,609,029 and 6,741,892, which are incorporated hereinby reference. The IPG 16 includes an outer case 34 formed from anelectrically conductive, biocompatible material, such as titanium and,in some instances, will function as an electrode.

The IPG 16 is typically programmed, or controlled, through the use ofthe external programmer 18. The external programmer 18 is coupled to theIPG 16 through a suitable communications link (represented by the arrow36) that passes through the patient's skin 38. Suitable links include,but are not limited to radio frequency (RF) links, inductive links,optical links, and magnetic links. The programmer 18 or other externaldevice may also be used to couple power into the IPG 16 for the purposeof operating the IPG 16 or replenishing a power source, such as arechargeable battery, within the IPG 16. Once the IPG 16 has beenprogrammed, and its power source has been charged or otherwisereplenished, the IPG 16 may function as programmed without the externalprogrammer 18 being present.

With respect to the stimulus patterns provided during operation of theSCS system 10, electrodes that are selected to transmit or receivestimulation energy are referred to herein as “activated,” whileelectrodes that are not selected to transmit or receive stimulationenergy are referred to herein as “non-activated.” Electrical stimulationwill occur between two (or more) electrodes, one of which may be the IPGcase 34, so that the electrical current associated with the stimulus hasa path from the energy source contained within the IPG case 34 to thetissue and a return path from the tissue to the energy source containedwithin the case 34. Simulation energy may be transmitted to the tissuein a monopolar or multipolar (e.g., bipolar, tripolar, etc.) fashion.

Monopolar stimulation occurs when a selected one of the lead electrodes20 is activated along with the case 34, so that stimulation energy istransmitted between the selected electrode 20 and case 24. Bipolarstimulation occurs when two of the lead electrodes 20 are activated asanode and cathode, so that stimulation energy is transmitted between theselected electrodes 20. For example, electrode E3 on the first lead 12may be activated as an anode at the same time that electrode E11 on thesecond lead 14 is activated as a cathode. Tripolar stimulation occurswhen three of the lead electrodes 20 are activated, two as anodes andthe remaining one as a cathode, or two as cathodes and the remaining oneas an anode. For example, electrodes E4 and E5 on the first lead 12 maybe activated as anodes at the same time that electrode E12 on the secondlead 14 is activated as a cathode.

Turning to FIG. 3, the IPG 16 has a plurality of dual current sources40. Each dual current source 40 includes a positive current source thatcan function as an anode (+I1, +I2, +I3, . . . +Icase) to “source”current to a load, as well as a current source that can function as acathode (−I1, −I2, −I3, . . . −Icase) to “sink” current from the load,through a common node 42. The load is the tissue that resides betweenthe activated electrodes 20, the wires (and other conductive elements),and the coupling capacitor (C1, C2, C3, . . . Ccase) that connects theassociated electrode 20 to the common node 49 of the dual current source40.

The IPG 16 programming will dictate which of the electrodes, i.e., thelead electrodes 20 and the case 34, will act as sources and sinks at anyparticular time. To that end, the IPG 16 is provided with a processor43, which receives control data from the external programmer 18 and aprogrammable current control circuit 44 that, in accordance with thecontrol data, causes selected dual current sources 40 to operate as ananode or a cathode, at specified times, to source or sink current havingpredetermined amplitude. The processor 43 may also provide status data,such as lead position or migration information (as will be described infurther detail below, as well as battery level, etc. The processor 43and control circuit 44 may be implemented as a microcontroller, whichtypically comprises a microprocessor and associated logic circuitry,which in combination with control logic circuits, timer logic, and anoscillator and clock circuit, generate the necessary control and statussignals which allow the microprocessor to control the operation of theIPG in accordance with the control data. Alternatively, the processor 43and control circuit 44 may be implemented as a hybrid arranging having aseparate digital IC for performing the data processing functions, and ananalog IC for controlling the current through the electrodes. In eitherarrangement, one or more memory devices (not shown) can be used to storecontrol data in the form of programming information, as well as anysoftware instructions utilized to perform the data processing functionsherein.

In the illustrated embodiment, where there are eight electrodes 20 onthe first lead 12 (labeled E1-E8), eight electrodes on the second lead14 (E9-E16), and an IPG case 34 that can function as an electrode(labeled Ecase), there are seventeen individually operable dual currentsources 40. The control circuit 44, which typically operates inaccordance with stored control data that is received from the programmer18, also turns off the selected dual current sources 40 at specifiedtimes. Alternative implementations may, however, employ fewer dualcurrent sources than there are electrodes. Here, at least some of thedual current sources will be connected to more than one electrodethrough a suitable multiplexer circuit. Alternative implementations mayalso be configured such that the IPG case 34 only functions as an anode,or such that the IPG case 34 only functions as a cathode.

The control circuit 44 may, in addition, be used to perform variousmeasurement functions. For example, the control circuit 44 may be usedto measure the electrode voltage V_(E1), V_(E2), V_(E3) . . . V_(E16) atthe output node 42 of each dual current source 40, whether the electrodeis activated or non-activated. This allows the electrode voltage at theelectrode to be measured which, in turn, facilitates lead migrationdetection, as will be described in further detail below.

Operation of the control circuit 44 may be explained in the context ofthe following example. Referring further to FIG. 4, the control circuit44 may be used to simultaneously turn on (or enable) the positivecurrent sources in the dual current sources 40 connected to leadelectrodes E1 and E2 during time T1. The negative current source in thedual current source 40 connected to lead electrode E9 is also turned onduring time T1. All other current sources are off (or disabled) duringthe time T1. This causes electrodes E1 and E2 to be activated as anodesat the same time that electrode E9 is activated as a cathode. Currents+I1 and +I2 are sourced from electrodes E1 and E2 at the same time thatcurrent −I9 is sunk into electrode E9. The amplitudes of the currents+I1 and +I2 may be any programmed values, and the amplitude of thecurrent −I9 should be equal to −(I1+I2). That is, the current that issourced is equal to the current that is sunk. After time period T1, thecontrol circuit 44 will typically switch the polarities of theelectrodes E1, E2, and E9 during a second time period T2, so that theelectrodes E1 and E2 will be activated as cathodes and the electrode E9will be activated as an anode.

Operating the control circuit 44 in this manner produces a biphasicstimulation pulse 46 illustrated in FIG. 4 that is characterized by afirst phase (period T1) of one polarity followed by a second phaseimmediately or shortly thereafter (period T2) of the opposite polarity.The electrical charge associated with the first phase should be equal tothe charge associated with the second phase to maintain charge balanceduring the stimulation, which is generally considered an importantcomponent of stimulation regimes, although this is not required by thepresent inventions. Charge balance of the biphasic stimulation pulse 46may be achieved by making the amplitudes of the first and second phases,as well as the periods T1 and T2, substantially equal. Charge balancemay also be achieved using other combinations of phase duration andamplitude. For example, the amplitude of the second phase may be equalto one-half of the amplitude of the first phase and the period T2 may beequal to twice the period T1. Rather than maintaining a precisecharge-balance, a passive recharge phase may be used to recover all the“recoverable” charge left on the electrode.

In an alternative embodiment, the SCS system 10 may include the IPG 16′illustrated in FIG. 5, which includes a plurality of dual voltagesources 40′ that are respectively connected to the lead electrodesE1-E16 and the IPG case electrode Ecase. Each dual voltage source 40′applies a programmed voltage to the associated electrode when turned onby way of a node 42′ and a coupling capacitor (C1, C2, C3, . . . Ccase).Alternative implementations may, however, employ fewer dual voltagesources than there are electrodes. Here, at least some of the dualvoltage sources will be connected to more than one electrode should asuitable multiplexer circuit. A processor 43′ receives control data fromthe external programmer 18 and transmits status data to the externalprogrammer 18, and a programmable voltage control circuit 44′ controlseach of the dual voltage sources 40′ and specifies the amplitude,polarity, and duration of the voltage that is applied to the electrodes20 in accordance with the control data.

The dual voltage sources 40′ and control circuit 44′ may be used toproduce the biphasic stimulation pulse 46′ illustrated in FIG. 6 that ischaracterized by a first phase (period T1) of one polarity followed by asecond phase immediately or shortly thereafter (period T2) of theopposite polarity applied between any two electrodes 20. Charge balanceof the biphasic stimulation pulse 46′ may be achieved by making theamplitudes of the first and second phases, as well as the periods T1 andT2, equal. Charge balance may also be achieved using other combinationsof phase duration and amplitude. For example, the amplitude of thesecond phase may be equal to one-half of the amplitude of the firstphase and the period T2 may be equal to twice the period T1. The controlcircuit 44′ may also be used to measure the current flowing to or fromeach electrode, whether the electrode is activated or not, as well aselectrode voltage (EV1-EV16) appearing at the common node 42′. Thesecurrent and voltage measurements also facilitate lead migrationdetection.

Additional details concerning the above-described and other IPGs may befound in U.S. Pat. No. 6,516,227, U.S. Patent Publication No.2003/0139781, and U.S. patent application Ser. No. 11/138,632, entitled“Low Power Loss Current Digital-to-Analog Converter Used in anImplantable Pulse Generator,” which are expressly incorporated herein byreference. It should be noted that rather than an IPG, the SCS system 10may alternatively utilize an implantable receiver-stimulator (not shown)connected to leads 12, 14. In this case, the power source, e.g., abattery, for powering the implanted receiver, as well as controlcircuitry to command the receiver-stimulator, will be contained in anexternal controller inductively coupled to the receiver-stimulator viaan electromagnetic link. Data/power signals are transcutaneously coupledfrom a cable-connected transmission coil placed over the implantedreceiver-stimulator. The implanted receiver-stimulator receives thesignal and generates the stimulation in accordance with the controlsignals.

The SCS system 10 is capable of detecting the occurrence and extent ofpost-implantation migration of the neurostimulation leads 12, 14 (i.e.,movement of the leads 12, 14 relative to the underlying tissue); forexample, from a base line lead arrangement, wherein the leads 12, 14have been initially implanted within tissue T in a parallel andnon-staggered relationship, as shown in FIG. 7, to a migrated leadarrangement, wherein the leads 12, 14 are in a parallel, but staggeredrelationship (two electrode offset), as shown in FIG. 8. Notably, whilethe baseline lead arrangement has been shown as being non-staggered,conceivably, a baseline lead arrangement can be non-staggered, and themigrated lead arrangement staggered, ultimately depending on the mannerin which the electrodes 20 are programmed. Thus, the SCS system 10 willbe capable of detecting the occurrence and extent of lead migration forany situation in which one of the leads moves from an intended positiondictated by the programmed electrodes.

Referring to FIG. 9, the lead migration detection process isaccomplished by generating actual electrical parameter data indicativeof the current position, orientation, and/or geometry of the leads 12,14 and computationally comparing that data to a plurality of previouslygenerated neurostimulation lead models, and in particular, estimates ofthe electrical parameter data corresponding to different predeterminedpositions, orientations and/or geometries of the leads 12, 14. Theposition, orientation and/or geometry corresponding to the model havingthe estimated electrical parameter data that best matches the measured(i.e., actual) electrical parameter data will be deemed the position,orientation and/or geometry of the leads 12, 14. The measured electricalparameter data and the lead models may be stored and processed by theIPG control circuit 44 (or 44′), by the external programmer 18, by somecombination thereof, or the like.

In the illustrated embodiment, the SCS system 10 determines the relativepositions between the leads 12, 14, and in particular, the staggerbetween the leads 12, 14. Thus, each model may be generated byestimating the electrical parameter data at each of a plurality ofstaggered positions between the leads 12, 14. Optionally, the SCS system10 may determine the relative orientation between the leads 12, 14, andin particular, the angle between the leads 12, 14. In this case, eachmodel may be generated by also estimating the electrical parameter dataat each of a plurality of staggered lead position and anglecombinations. In other optional embodiments, the SCS system 10 may evendetermine the geometry (e.g., curvature) of the leads 12, 14. Thus, inthis case, each model may be generated by also estimating the electricalparameter data at each of a plurality of staggered lead position, angle,and curvature combinations.

Notably, it may be necessary to constrain the lead models to provide aunique solution. That is, determining the position, angle, and curvatureof a neurostimulation lead may present electrical inverse problems,which absent constraints, typically do not results unique solutions. Thelead models should not be over-constrained, such that they do not yieldany useful information (i.e., information that cannot be used todetermine migration of the leads), and should not be under-constrained,such that there is not a unique solution (i.e., more than one lead modelwill contain substantially the same electrical parameter data). Thus, itmay be preferred that the lead models be constrained, such that onlyrelative position between the leads 12, 14 (i.e., stagger) bedetermined. In this case, each lead model assumes that the leads 12, 14have a rectilinear geometry and are parallel to each other. In thiscase, it is ensured that the lead models return a unique solution. Whilethe SCS system 10 may not be able to detect lateral migration of theleads 12, 14, which may otherwise be detected if the relativeorientation of the leads 12, 14 were modeled, much of the problemsassociated with lead migration result from movement of one of the leads12, 14 along its length, which will be capable of being detecting bydetermining the lead stagger.

In the illustrated embodiment, the electrical parameter data that ismeasured (and thus modeled) is voltage potential data of an electricalfield generated by selected ones of the lead electrodes 20 (individuallyidentified as E1-E16) and recorded at other selected ones of the leadelectrodes 20. This may be accomplished in one of a variety of manners.For example, anytime after the leads 12, 14 have been properlypositioned within tissue (“proper” positioning varies from patient topatient), an electrical field may be generated by sourcing a currentfrom a selected one of the electrodes 20 and sunk at the IPG outer case34. Alternatively, multipolar configurations (e.g., bipolar or tripolar)may be created between the lead electrodes 20. It should be noted thatthe current used for generating the electrical field may be asub-threshold current pulse (e.g., 1 mA for 20 μs) that will not causestimulation or substantially drain the IPG battery. Alternatively, anelectrode that is sutured (or otherwise permanently or temporarilyattached (e.g., an adhesive or gel-based electrode) anywhere on thepatient's body may be used in place of the case IPG outer case 34 orlead electrodes 20.

In either case, while a selected one of the electrodes E1-E16 isactivated to generate the electrical field, a selected one of theelectrodes E1-E16 (different from the activated electrode) is operatedto record the voltage potential of the electrical field. This processcan be repeated for different electrical field generating electrodes anddifferent voltage potential recording electrodes. In the preferredembodiment, selected ones of the electrodes 20 are sequentially operatedto generate electrical fields. In one embodiment, selected ones of theelectrodes 20 are sequentially operated to record the field potentials,in which case, a single recording circuit will suffice. In anotherembodiment, multiple recording circuits can be employed, in which case,selected ones of the electrodes 20 can be simultaneously operated torecord the field potentials, thereby reducing processing time.

In any event, for each electrical field generated by one of the leadelectrodes 20, selected others of the lead electrodes 20 are used torecord the voltage potentials of the electrical field, thereby creatinga two-dimensional array of data having electrical field generatingelectrodes in one dimension of the data array, and recording electrodesin the other dimension of the data array. For example, referring to FIG.9, an exemplary two-dimensional array of recorded field potential datais shown, wherein the rows represent the particular electrodes E1-E16used to create the electrical fields, and columns represent theparticular electrodes E1-E16 used to record the voltage potentials ofthe electrical fields. Thus, the two-dimensional array contains arecorded field potential for each pair of field generating/recordingelectrodes (e.g., (E1,E10), (E9, E2), etc.).

While all of the electrodes E1-E16 can be used create electrical fieldsand record voltage potentials, thereby creating 240 electrodecombinations (electrodes cannot be used to both generate electricalfields and record voltage potentials, and therefore, a number ofelectrode combinations (in this case, 16) cannot be used) and 240corresponding field potential data items, the combinations of electrodesE1-E16 most relevant to determining movement of the leads 12, 14 areused in the illustrated embodiment. For example, in the illustratedembodiment, the SCS system 10 determines the relative positions betweenthe leads 12, 14, and in particular, the stagger between the leads 12,14. Optionally, the SCS system 10 may even determine the relativeorientation between the leads 12, 14, and in particular, the anglebetween the leads 12, 14. Thus, only voltage potentials recorded on alead opposite to the lead generating the electrical field will be usefulin determining stagger, or optionally the angle between the leads 12,14.

In this case, the most pertinent combinations of electrodes E1-E16 arethose combinations that includes electrodes on different leads 12, 14;that is, one of the electrodes E1-E8 on the first lead 12 as one of theelectrical field generating electrode or voltage potential recordingelectrode, and one of the electrodes E9-E16 on the second lead 14 as theother of the electrical field generating electrode or voltage potentialrecording electrode. Thus, as illustrated in FIG. 10, thetwo-dimensional array includes voltage potential entries correspondingto electrode combinations on opposite leads, as represented by theregions indicated with “i”.

Optionally, the SCS system 10 may determine the geometry of one or bothof the leads 12, 14 (e.g., the curvature). In this case, combinations ofelectrodes E1-E16 on the same lead, as well as combinations ofelectrodes E1-E16 on opposite leads, will provide useful information. Itshould be appreciated that if processing time or data storage becomes anissue, the resolution of the electrodes E1-E16 used to generateelectrical fields and record voltage potentials may be decreased if someaccuracy can be sacrificed. For example, instead of using all electrodesE1-E16 to generate electrical fields and record voltage potentials,every other ones of the electrodes E1-E16 (e.g., only the odd numberedelectrodes) may be used to generate electrical fields and record voltagepotentials, as illustrated in FIG. 11. In this case, the amount of datastored and processed will be reduced by seventy-five percent.

The amount of data stored and processed may also be reduced by usingonly unidirectional data, since generating an electrical field on afirst electrode (e.g., E1) and recording the voltage potential on asecond electrode (e.g., E13) should yield the same result as generatingan electrical field on the second electrode (e.g., E13) and recordingthe voltage potential on the first electrode (e.g., E1). In this case,roughly half of the data contained in a two-dimensional electrode arraymay be considered redundant (the diagonal and either the upper-right orlower-left triangles would be considered useful information). When theconcept of using only unidirectional data is applied to the electrodearrays of FIGS. 10 and 11, which assume that the relative positions ofleads will be assessed (i.e., cross-lead data will be critical (i.e.,sourcing/sinking current on a contact of one lead and measuring data,such as a field potential, on a contact of a different lead), wheresame-lead data will not be as useful). As a result, the amount of datastored and processed, after removing same lead data, will be furtherreduced by 50%; that is, only the data “i” currently shown in thetop-right quadrants of FIGS. 10 and 11 will be collected (although onlythe data “I” currently shown in the bottom-left quadrant can becollected if, instead, the electrodes E9-E16 are used to generateelectrical fields, and electrodes E1-E8 are used to record voltagepotentials.

Significantly, each of the lead models would similarly be represented astwo-dimensional arrays; that is, two-dimensional arrays wherein the rowsrepresent the electrodes E1-E16 used to create the electrical fields,and columns represent the electrodes E1-E16 used to record the voltagepotentials of the electrical fields. The lead models may, e.g., be basedon an analytical model, spatially discretized model (e.g., finiteelement, boundary element), or an empirical data-based model. In thecase of an analytical model, the tissue may be modeled as a homogenousmass, and the stimulating electrode may be modeled as a point source. Inthe case of a spatially discretized model, the different tissues, suchas fat, collagen, bone, ligament, the white and gray matter of thespinal cord, and dura can be discretely modeled.

It should be noted that, while the present invention lends itself wellto the determination of relative positions, or optionally orientations,between leads, the SCS system 10 may be modified, so that the absoluteposition and/or orientation of a lead can be determined. In this case,one or more electrodes (not shown), such as a bone screw electrode orotherwise an electrode fixed relative to an anatomical feature (such asa bone), can be used. The fixed electrode(s) can either generate theelectrical fields (with the lead electrodes 20 recording the voltagepotentials) and/or record the voltage potentials (with the leadelectrodes 20 generating the electrical fields). In this manner, theabsolute position and/or orientation (i.e., relative to anatomicalfeature), can be determined.

While voltage potential data has been described as the electricalparameter data that is measured, it should be appreciated that othertypes of electrical parameter data, such as impedance data, can bemeasured. For example, the impedance between selected bipolar pairs ofthe electrodes E1-E16 may be measured, e.g., by transmitting a constantcurrent between the selected bipolar pairs, measuring the voltagepotential at the bipolar pairs, and calculating the impedance based onthe constant current value and voltage potential measurements. Furtherdetails describing the measurement of electrical parameter data, such asvoltage potential data and impedance data, are disclosed in U.S. Pat.No. 6,993,384, which is expressly incorporated herein by reference.

To determine which of the modeled estimated electrical parameter databest matches the measured electrical parameter data, the data can becomputationally compared with each other using any one of a variety ofcomparison functions.

For example, one comparison function that can be used is a correlationcoefficient function, such as a Pearson Correlation Coefficientfunction, which can be expressed as the following equation:

${r = \frac{\sum\limits_{i}{\left( {{AD}_{i} - M_{AD}} \right)\left( {{ESTi} - M_{EST}} \right)}}{{sqrt}\left( \; {\sum\limits_{i}{\left( {{AD}_{i} - M_{AD}} \right){\sum\limits_{i}\left( {{ESTi} - M_{EST}} \right)^{2}}}} \right)}},$

wherer is the coefficient, AD represents the actual (measured) data set(e.g., the two-dimensional arrays illustrated in FIG. 10 or 11), ESTrepresents the model-based estimate of the data set (e.g., thetwo-dimensional modeled arrays corresponding to the arrays of FIG. 10 or11), M represents the mean of the data set (either actual or modeled),and i represents a single element of the data set (either actual ormodeled) (i.e., the data generated by a single combination of electrodes(e.g., E1, E9). Advantageously, the correlation coefficient is notsensitive to magnitude scaling, and ranges from −1 (perfect inversecorrelation) to 1 (perfect correlation). With this function, we seek amaximum—the highest correlation between the actual data and themodel-based estimated of the data.

Another comparison function that can be used is a least squares basedfunction, and in particular, a sum of squared differences function,which can be expressed as the following equation:

${{SSD} = {\sum\limits_{i}\left( \left( {{AD}_{i} - {EST}_{i}} \right)^{2} \right)}},$

whereSSD is the sum of squared difference, and AD, EST, and i have beendefined above. The SSD function measures the difference between theactual data and an instance of the model-based estimate of the data.With this function, we seek a minimum—the instance of the model yieldingestimates that are the least different from the actual data. Othercomparison functions, including cross-correlation functions, waveletfunctions, and associated matching measures, may be alternatively used.

FIG. 12 shows the results of a data comparison using a PearsonCorrelation Coefficient function, with the x-axis representing astaggered lead position, and the y-axis representing the coefficientvalue. FIG. 13 shows the results of a data comparison using the SSDfunction, with the x-axis representing a staggered lead position, andthe y-axis representing the SSD value. The plots of FIGS. 12 and 13 werecreated using Matlab to both generate the “actual voltage potentialdata” and the model-based estimates of the voltage potential data. Inparticular, using the electrode combinations illustrated in FIG. 10, the“actual voltage potential data” was modeled using an analytical pointsource model with leads separated by 5 mm, staggered by 14 mm, and withGaussian white noise (stdev=25 mv). The maximum voltage of the “actualvoltage potential data” was 497.4 mV in the absence of noise. Using thesame electrode combinations, models of estimated voltage potential datawere created using an analytical point source model with leads separatedby 2 mm over thirty-three different staggered lead positions. The“actual voltage potential data set” was then computationally compared tothese models using the Pearson Coefficient function to create the plotof FIG. 12 and using the SSD function to create the plot of FIG. 13.

As can be seen, each data point in the plot of FIG. 12 represents astaggered lead position with a corresponding coefficient value, and eachdata point in the plot of FIG. 13 represents a staggered lead positionwith a corresponding SSD value. As would be expected, the particulardata point having the staggered lead position of 14 mm corresponds tothe highest coefficient value in the plot of FIG. 12 and the lowest SSDvalue in the plot of FIG. 13. In both cases, the estimated position of14 mm will correctly be selected as the determined staggered position ofthe leads.

The corrective action that may be taken after it has been determinedthat one or more of the leads 12, 14 in the SCS system 10 has movedgenerally falls into two categories—(1) surgical removal orrepositioning and (2) reprogramming. Surgical removal or repositioningwill typically be employed when it has been determined that one or moreof the leads 12, 14 has moved too far to make reprogramming a viableoption. If, for example, the therapeutic regimen required that anelectrode be located in the baseline location of electrode E2 on lead 12shown in FIG. 7, the therapeutic regimen could not be performed oncelead 12 migrated to the location shown in FIG. 8 because there is nolong any electrode in that location. Surgical removal may also berequired if one or more of the electrodes are damaged or fails.

With respect to reprogramming, individuals information concerning theactual movement (or lack of movement) of each lead 12, 14 will allowreprogramming to proceed in a far more efficient manner than would bethe case if the entity tasked with reprogramming (i.e., a physician orthe SCS system 10) merely know that at least one of the leads 12, 14have moved due to a change in their relative positions. Assuming, forexample, that the leads 12, 14 illustrated in FIG. 7 were employed in atherapeutic regimen that involved sourcing and sinking stimulationpulses from electrodes E4, E5, and E6 on lead 12 and electrodes E13 andE14 on lead 14, after lead 12 moved to the position illustrated in FIG.8, and it was determined that only lead 12 moved and that it movedtoward the IPG 16 a distance corresponding to two electrodes, thetherapeutic regimen may be reprogrammed by simply substitutingelectrodes E2, E3, and E4, respectively, for electrodes E4, E5, and E6.

Reprogramming may be performed automatically or by a clinician.Automatic reprogramming, which is especially useful when lead migrationis being continuously monitored, could be truly automatic (i.e., itwould happen without the patient's knowledge). Alternatively, the IPG 16could provide the patient with an indication that at least one lead 12,14 has moved and provide the patient the option of trying theautomatically reprogrammed stimulation regimen or simply reporting thelead migration to the clinician. Reprogramming by the clinician, eitherin response to a notification from the IPG 16 or patient complaint,would typically involve allowing the external programmer 18 to modify(or simply suggest a modification of) the therapeutic regimen based onthe lead migration data from the IPG 16. Alternatively, the leadrepositioning is recorded for the clinician to review for use duringreprogramming, thereby reducing the amount of clinician time (andexpense) required to reprogram the therapeutic regimen, as well as thelikelihood that an expensive fluoroscopic procedure will be required.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

1-69. (canceled)
 70. An external control device for use with implantableneurostimulation leads, each having a plurality of electrodes,comprising: memory storing a plurality sets of estimated electricalparameter data sets, each corresponding to a predetermined relativeposition between the neurostimulation leads; and a processor configuredfor comparing measured electrical parameter data with the estimatedelectrical parameter data of each the sets, and determining a relativeposition between the neurostimulation leads based on the comparison, themeasured electrical parameter data having been measured in response toelectrical energy transmitted to or from the electrodes of theneurostimulation leads.
 71. The external control device of claim 70,wherein the determined relative position is a stagger between theneurostimulation leads.
 72. The external control device of claim 70,wherein the estimated electrical parameter data and the measuredelectrical parameter data are electrical field potential data.
 73. Theexternal control device of claim 70, wherein the determined relativeposition is the predetermined relative position corresponding to theestimated electrical parameter data that best matches the measuredelectrical parameter data.
 74. The external control device of claim 70,wherein the comparison is performed computationally.
 75. The externalcontrol device of claim 74, wherein the comparison is computationallyperformed using a comparison function selected from the group consistingof a correlation coefficient function, a least squares based function,and a cross-correlation function.
 76. The external control device ofclaim 70, wherein each of the sets of estimated electrical parameterdata is included in a neurostimulation lead model selected from thegroup consisting of an analytical model, a spatially discretized model,and an empirical data-based model.
 77. The external control device ofclaim 70, wherein the estimated electrical parameter data in each of thesets comprises a two-dimensional array of data having transmitting onesof the electrodes in one dimension of the data array, and recording onesof the electrodes in the other dimension of the data array.
 78. Theexternal control device of claim 70, wherein the processor is furtherconfigured for determining whether one of the neurostimulation leads hasmigrated based on the determined relative position.
 79. The externalcontrol device of claim 78, wherein the processor is further configuredfor reprogramming the electrodes in response to a determination that theone neurostimulation lead has migrated.
 80. An external control devicefor use with an implantable neurostimulation lead having a plurality ofelectrodes, comprising: memory storing a plurality of sets of estimatedelectrical parameter data corresponding to a predetermined position ofthe neurostimulation lead; and a processor configured for comparing themeasured electrical parameter data with the estimated electricalparameter data of each of the sets, and determining a position of theneurostimulation lead based on the comparison, the measured electricalparameter data having been measured in response to electrical energytransmitted to or from the electrodes of the neurostimulation leads. 81.The external control device of claim 80, wherein the position of theneurostimulation lead is determined relative to another neurostimulationlead.
 82. The external control device of claim 81, wherein thedetermined relative position is a stagger between the neurostimulationleads.
 83. The external control device of claim 80, wherein the positionof the neurostimulation lead is determined relative to an anatomicalfeature.
 84. The external control device of claim 80, wherein theestimated electrical parameter data and the measured electricalparameter data are electrical field potential data.
 85. The externalcontrol device of claim 80, wherein the determined position is thepredetermined position corresponding to the estimated electricalparameter data that best matches the measured electrical parameter data.86. The external control device of claim 80, wherein the comparison isperformed computationally.
 87. The external control device of claim 80,wherein the comparison is computationally performed using a comparisonfunction selecting from the group consisting of a correlationcoefficient function, a least squares based function, and across-correlation function.
 88. The external control device of claim 80,wherein each of the sets of estimated electrical parameter data isincluded in a neurostimulation lead model selected from the groupconsisting of an analytical model, a spatially discretized model, and anempirical data-based model.
 89. The external control device of claim 80,wherein the processor is further configured for determining whether theneurostimulation lead has migrated based on the determined position. 90.The external control device of claim 89, wherein the processor isfurther configured for reprogramming the electrodes in response to adetermination that the neurostimulation lead has migrated.